Acasti Announces Alignment with FDA on GTX-104 Pivotal Phase 3 Safety Trial Protocol and Confirms Planned Initiation of STRIVE-ON in aSAH Patients in Calendar Q4 2023
LAVAL, QC, July 5, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel injectable nimodipine formulation for intravenous infusion (IV) that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company has aligned with the U.S. Food and Drug Administration (FDA) on the protocol for its pivotal Phase 3 trial of GTX-104 and the FDA also provided guidance for a potential GTX-104 New Drug Application (NDA) package.
- Acasti has all the necessary information from the FDA to initiate its recently named STRIVE-ON (Safety, Tolerability, Randomized, IV and Oral Nimodipine) pivotal Phase 3 trial of GTX-104 to evaluate its safety and tolerability profile relative to oral nimodipine.
- We look forward to the completion of the STRIVE-ON trial, and if approved by the FDA, GTX-104 could bring enhanced options for physicians treating patients suffering from aSAH."
- STRIVE-ON will be a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH.
- Key trial design features include:
Approximately 100 patients will be enrolled at an estimated 25 hospitals in the U.S.